Cleared Special

K132857 - RESPIRATORY GAS HUMIDIFIER

K132857 is an FDA 510(k) clearance for RESPIRATORY GAS HUMIDIFIER, manufactured by Pacific Medico Co., Ltd.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Special 510(k) pathway after a 231-day FDA review.

K132857 · Pacific Medico Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
231d
Days
Class 2
Risk

K132857 is an FDA 510(k) clearance for the RESPIRATORY GAS HUMIDIFIER. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Pacific Medico Co., Ltd. (Bunkyo-Ku, Tokyo, JP). The FDA issued a Cleared decision on May 1, 2014 after a review of 231 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5450 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K132857

510(k) Number K132857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2013
Decision Date May 01, 2014
Days to Decision 231 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 140d · This submission: 231d
Pathway characteristics
Modification to existing cleared device.

BTT Device Classification - Class 2, Special Controls

Product Code BTT Humidifier, Respiratory Gas, (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5450
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BTT Humidifier, Respiratory Gas, (direct Patient Interface)

All 179
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